This document outlines the requirements and conditions for obtaining different types of licenses to manufacture, repack, or loan drugs in India. The key types of licenses covered are:
1. Manufacturing license - Issued to those who can independently manufacture and test drugs. Separate licenses are needed for different drug classes.
2. Loan license - Issued to those who want to use another licensed manufacturer's facilities. They must demonstrate adequate testing capabilities.
3. Repacking license - Allows breaking bulk drugs into smaller packages and relabeling for sale. Testing of materials and products is required.
Stringent good manufacturing practices, record keeping, and testing standards apply to all license types to ensure drug quality and safety
These presentation describes the rules and regulations for the manufacture of drugs and grant of license. Loan License and Repacking License is also described. These presentation is the part of series Drugs & Cosmetics Act.
This presentation is related to the drug price control order in India. It will give an idea to the readers how the prices have been fixed for the formulations. How the price has been calculated for scheduled formulations.
The government has notified the DPCO 2013 under the Essential Commodities Act, 1955, which will give power to the NPPA (National Pharmaceutical Pricing Authority (NPPA )to regulate prices of 348 essential drugs along with their specified strengths and dosages under NLEM 2011.
These presentation describes the rules and regulations for the manufacture of drugs and grant of license. Loan License and Repacking License is also described. These presentation is the part of series Drugs & Cosmetics Act.
This presentation is related to the drug price control order in India. It will give an idea to the readers how the prices have been fixed for the formulations. How the price has been calculated for scheduled formulations.
The government has notified the DPCO 2013 under the Essential Commodities Act, 1955, which will give power to the NPPA (National Pharmaceutical Pricing Authority (NPPA )to regulate prices of 348 essential drugs along with their specified strengths and dosages under NLEM 2011.
At the end of the 19th century and early 20 century use of Allopathy system increases
Drugs of natural origin: Veg, mineral oil and animals
At that time, profit became main motive than service
Overdose of quinine.A Central law to control drugs and pharmacy profession.
Codes of pharmaceutical ethics
In relation to his trade
In relation to his Job
In relation to his Profession
In relation to Medical Profession
Pharmacist's Oath
Medicinal and toilet preparations act and rules,1955Ganesh Shevalkar
It is an Act with provision for levy and collection of excise duties on medicinal and toilet preparations containing alcohol, opium, Indian hemp (cannabis) or other narcotic drugs.
Drugs and Cosmatic Act,1940 and its rules 1945TameshSonkar
Objectives, Definitions, Legal definitions of schedules to the Act and Rules
Import of drugs Classes of drugs and cosmetics prohibited from import
,Import under license or permit. Offences and penalties.
Manufacture of drugs Prohibition of manufacture and sale of certain drugs
Conditions for grant of license and conditions of license for manufacture of
drugs, Manufacture of drugs for test, examination and analysis
,manufacture of new drug, loan license and repacking license.
Narcotic Drugs and Psychotropic Substances Act, 1985Ganesh Shevalkar
The Narcotic Drugs and Psychotropic Substances Act, 1985, commonly referred to as the NDPS Act, is an Act of the Parliament of India that prohibits a person to produce/manufacture/cultivate, possess, sell, purchase, transport, store, and/or consume any narcotic drug or psychotropic substance.
Guideline for application and grant of manufacturing and selling of pharmaceutical drugs , cosmetics, biologics and medical devices to be followed by pharmaceutical industry.
The prevention of cruelty to animals act 1960Shaik Rasheed
This presentation give the complete information regarding the The Prevention of Cruelty to Animals Act 1960 including the definitions, composition of IAEC, Breeding and stocking of animals, experiments, offences and penalties.
The application for Registration and import can be made to the Licensing Authority under the Act i.e. to the Drugs Controller General at CDSCO. Drug and Cosmetic Act 1945: It Contains provisions for classification of drugs under given schedules. Guidelines for the storage,sale,display and prescription of each schedule.
The Prevention of Cruelty to Animals Act, 1960, authored by acclaimed dancer and animal lover, Rukmini Devi Arundale, is an Act of the Parliament of India enacted in 1960 to prevent the infliction of unnecessary pain or suffering on animals and to amend the laws relating to the prevention of cruelty to animals.
manufacture of drugs - License. Drugs and cosmetic act 1940 and rules 1945Swarna kumari S
Manufacture of drugs - License. Drugs and cosmetic act 1940 and rules 1945. Licences are required for the manufacturing of following categories of drugs. PROHIBITED TO BE MANUFACTURED OR SOLD IN OUR COUNTRY. condition Precedent and condition subsequent
At the end of the 19th century and early 20 century use of Allopathy system increases
Drugs of natural origin: Veg, mineral oil and animals
At that time, profit became main motive than service
Overdose of quinine.A Central law to control drugs and pharmacy profession.
Codes of pharmaceutical ethics
In relation to his trade
In relation to his Job
In relation to his Profession
In relation to Medical Profession
Pharmacist's Oath
Medicinal and toilet preparations act and rules,1955Ganesh Shevalkar
It is an Act with provision for levy and collection of excise duties on medicinal and toilet preparations containing alcohol, opium, Indian hemp (cannabis) or other narcotic drugs.
Drugs and Cosmatic Act,1940 and its rules 1945TameshSonkar
Objectives, Definitions, Legal definitions of schedules to the Act and Rules
Import of drugs Classes of drugs and cosmetics prohibited from import
,Import under license or permit. Offences and penalties.
Manufacture of drugs Prohibition of manufacture and sale of certain drugs
Conditions for grant of license and conditions of license for manufacture of
drugs, Manufacture of drugs for test, examination and analysis
,manufacture of new drug, loan license and repacking license.
Narcotic Drugs and Psychotropic Substances Act, 1985Ganesh Shevalkar
The Narcotic Drugs and Psychotropic Substances Act, 1985, commonly referred to as the NDPS Act, is an Act of the Parliament of India that prohibits a person to produce/manufacture/cultivate, possess, sell, purchase, transport, store, and/or consume any narcotic drug or psychotropic substance.
Guideline for application and grant of manufacturing and selling of pharmaceutical drugs , cosmetics, biologics and medical devices to be followed by pharmaceutical industry.
The prevention of cruelty to animals act 1960Shaik Rasheed
This presentation give the complete information regarding the The Prevention of Cruelty to Animals Act 1960 including the definitions, composition of IAEC, Breeding and stocking of animals, experiments, offences and penalties.
The application for Registration and import can be made to the Licensing Authority under the Act i.e. to the Drugs Controller General at CDSCO. Drug and Cosmetic Act 1945: It Contains provisions for classification of drugs under given schedules. Guidelines for the storage,sale,display and prescription of each schedule.
The Prevention of Cruelty to Animals Act, 1960, authored by acclaimed dancer and animal lover, Rukmini Devi Arundale, is an Act of the Parliament of India enacted in 1960 to prevent the infliction of unnecessary pain or suffering on animals and to amend the laws relating to the prevention of cruelty to animals.
manufacture of drugs - License. Drugs and cosmetic act 1940 and rules 1945Swarna kumari S
Manufacture of drugs - License. Drugs and cosmetic act 1940 and rules 1945. Licences are required for the manufacturing of following categories of drugs. PROHIBITED TO BE MANUFACTURED OR SOLD IN OUR COUNTRY. condition Precedent and condition subsequent
Confederation of indian industry recommendations for guideline changes in the...Dr. Rajesh Jain
Confederation of indian industry recommendations for Guideline Changes in the Vaccine approval procedures to the ministry of health & family welfare
Requirements And Guidelines For Permission To Import / or Manufacture of New Drugs For Sale or To Undertake Clinical Trials
Schedule Y was introduced under the Drugs and Cosmetics Act 1940, to
introduce requirements for countries to get permission for:
Importing
Manufacturing new drugs
Conducting Clinical Trials.
Application for permission
Clinical Trial
Studies in specific population
Post marketing surveillance
Special studies: BA/BE studies
Sale of Drugs – Wholesale, Retail sale and Restricted license. Offences and penalties
Labeling & Packing of drugs- General labeling requirements and specimen labels for
drugs and cosmetics, List of permitted colors. Offences and penalties.
IIMPORT AND REGISTRATION AS PER DRUG AND COSMETIC ACT Sagar Savale
The drug and cosmetic act was passed on 10th April, 1940.
Objective : To regulate the import, manufacture, distribution, and sale of Drug and Cosmetics.
All classes of the drugs and cosmetics imported into India, shall comply with the prescribed standards and labels.
Manufacture of all classes of drug require prior license.
Indian regulatory requirements - industrial pharmacy 2Jafarali Masi
Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs
Commercial medical devices in Colombia require registration with INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), the country’s medical device regulator. Classification of devices in Colombia follows a four-tiered risk model (Class I, Class IIa, Class IIb and Class III). Colombia’s device classification system is similar to those of the European Union and other Global Harmonization Task Force (GHTF) systems. If the device falls into a lower-risk category in Colombia (Class I or IIa), the company will qualify for an automatic certificate upon notification to INVIMA —it will be able to sell its devices immediately.
Adv. biopharm. APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMSAkankshaAshtankar
MIP 201T & MPH 202T
ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS : UNIT 5
APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMS By - AKANKSHA ASHTANKAR
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
CDSCO and Phamacovigilance {Regulatory body in India}NEHA GUPTA
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. Operating under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, the CDSCO is responsible for approving new drugs, conducting clinical trials, setting standards for drugs, controlling the quality of imported drugs, and coordinating the activities of State Drug Control Organizations by providing expert advice.
Pharmacovigilance, on the other hand, is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The primary aim of pharmacovigilance is to ensure the safety and efficacy of medicines, thereby protecting public health.
In India, pharmacovigilance activities are monitored by the Pharmacovigilance Programme of India (PvPI), which works closely with CDSCO to collect, analyze, and act upon data regarding adverse drug reactions (ADRs). Together, they play a critical role in ensuring that the benefits of drugs outweigh their risks, maintaining high standards of patient safety, and promoting the rational use of medicines.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
4. INTRODUCTION
License issued in a specified form for
manufacture of specified category of drugs.
For license, applications made in a prescribed
form to the licensing authority.
Separate license for manufacturing of drugs at
more than one premises. Hence, a separate
application form.
License granted on satisfaction with the
fulfillment of the provisions under the D&C Act
1940.
5. * License renewed from time to time.
* Before granting license the license issuing
authority send the inspectors who examines:
Premises
Plant and appliances
Process of manufacture
6. Means to be employed in standardizing and
the substance to be manufactured.
Testing the substance to be manufactured.
Professional qualification of the technical staff
to be employed.
Report forwarded to the licensing authority by
the inspector.
After complete satisfaction of the provisions a
license is issued in a prescribed form along
with a triplicate copy of it.
7. TYPES OF LICENSES
Types of licenses granted for the
manufacturing of drugs for sale:-
1. License for manufacturing of drugs.
2. Loan licenses for manufacturing of
drugs.
3. Repacking license
8. 1.Manufacturing license
Issued to a person or organization
who have their own arrangements
for the manufacturing and
standardization of drugs.
Different licenses required to
manufacture different class of
drugs.
9. 2.Loan license
Issued to a person who does not have his
own arrangements for manufacture but
who intends to avail himself of the
manufacturing facilities owned by
another licensee.
10. Before granting the license, the licensing
authority shall be satisfied about the
manufacturing unit regarding the
following:-
a. Adequate equipment and staff
b. Capacity for manufacture
c. Facilities for testing
11. 3.Repacking license
Granted for the purpose of breaking up any
drug from a bulk container into small
packages and the labelling of each package
with a view to its sale and distribution (but does
not include compounding or dispensing).
Issued for drugs other than those specified in
schedules C & C1 and schedule X.
Application made in a specified form
accompanied with the prescribed fees.
12. FORM NUMBERS
TYPE OF LICENSE CLASS OF DRUGS FORMS
App Grant of Renew
license Certif
1. Manufacture of drugs a. Grant of or renewal
for sale and distribution of a license to
manufacture drugs 24 25 26
other than those
specified in Sch C,
C1 & part XB.
b. To manufacture for
sale drugs specified 24F 25F 26F
in Schedule X and
part XB.
c. To manufacture
drugs specified in
Sch C, C1 excluding 27 28 26
those specified in
Sch X and part XB.
13. Types of Class of drugs App. GOL RC
license
d. To manufacture drugs 27B 28B 26
specified in Sch C, C1 & X.
e. For manufacture or sale or
for distribution of large
volume parentrals/sera 27D 28D 26H
and vaccines excluding
those specified in Sch X
and part XB.
f. To manufacture drugs for
the purpose of 30 29 License
examination, test or not
analysis. renewed
14. Types of Class of drugs App. GOL RC
license
2. Loan a. To manufacture drugs 24A 25A 26A
license other than those
specified in Sch C, C1 &
X.
b. To manufacture for sale 27A 28A 26A
of drugs specified in Sch
C & C1.
3. Repacking a. To repack for sale and
license distribution of drugs other 24B 25B 26B
than those specified in Sch
C, C1 & X.
15. GENERAL CONDITIONS
Manufacture conditions for the grant or renewal of
license in form 25 or 25F (for drugs other than those
specified in Sch C, C1 & X) (Rule 71):-
1. Manufacture conducted under the supervision of
competent and at least one full time employee.
Competent technical staff:
a. B.Pharma/ M.Pharma (Pharma. Chem) or equivalent
qualification with 18 months prac experience in
manft of drugs or 1yr if done training in manft of
drugs for 6months during the university course.
16. b. Graduate in Science with Chemistry as a principle
subject and has at least 3yrs prac experience in
the manufacture of drugs after his graduation.
c. Graduate in Chem Engg or Chem Techn or
Medicine with general training and practical
experience, extending over a period of not less
than 3yrs in the manufacture of drugs, after his
graduation.
d. Any foreign qualification which is comparable with
those prescribed in (a), (b) or (c).
17. 2. Factory premises in compliance with Schedule
M.
3. Adequate space, plant and equipment for the
manufacturing operations.
4. Provision and maintenance of adequate
staff, premises and laboratory equipment for
carrying out tests of the strength, quality and
purity of the substances at a testing unit, which
shall be separate from the manufacturing unit
and the head of the testing unit shall be
independent of the head of the manufacturing
unit.
18. 5. Adequate arrangements for the storage of drugs
manufactured.
6. The applicant shall, while applying for a licence
to manufacture patent or proprietary medicines,
furnish to the Licensing Authority evidence and
data justifying that the patent or proprietary
medicines:-
a) Contain the constituent ingredients.
b) Are safe for use in the context of the vehicles,
excipients, additives and pharmaceutical aids
used in the formulation.
19. c) Are stable under the conditions of storage
recommended.
d) Contain such ingredients and in such
quantities for which there is therapeutic
justification.
e) Have the approval.
7. Licensee shall comply with the requirements
of Good Manufacturing Practices as laid
down in Schedule M.
20. Manufacture conditions for the grant or
renewal of license in form 25 or 25F (for drugs
other than those specified in Sch C, C1 & X)
(Rule 74):-
1. Provide and maintain staff, premises
and the equipment as specified in rule
71.
2. Shall comply with the provisions of the
Act and of these rules and with such
further requirements.
21. 3. Shall either in his own laboratory or in any
other laboratory approved by the Licensing
Authority test each batch or lot of the raw
material for the manufacture of products and
also each batch of the final product and shall
maintain records or registers showing the
particulars in respect of such tests as specified
in Schedule U. The records or registers shall be
retained for a period of 5 years from the date
of manufacture .
22. 4. Shall keep records of the details of
manufacture as per particulars given in
Schedule U. Records shall be retained for a
period of five years.
5. Shall allow an Inspector to enter, with or
without prior notice, any premises and to
inspect the plant and the process of
manufacture and the means employed in
standardizing and testing the drugs.
23. 6. Shall allow an Inspector to inspect all registers
and records, take samples of the
manufactured drugs and supply information
as he may require for the purpose of
ascertaining whether the provisions of the Act
and the rules thereunder have been
observed.
24. 7. Shall report to the Licensing Authority any
changes in the expert staff responsible for the
manufacture or testing of the drugs and any
material alterations in the premises or plant
used for the purpose which have been made
since the date of the last inspection made on
behalf of the licensing authority.
25. 8. Shall furnish to the Licensing Authority, the
Controlling Authority or to such authorities as
they may direct from every batch, or batches
of drugs, a sample of such quantity as may be
considered adequate by such authority for
any examination and, if so required, also
furnish full protocols of tests which have been
applied.
26. 9. Any part of any batch of the drug has been
found not to conform with the standards of
strength, quality or purity as specified, the
remainder of the batch from sale should be
withdrawn.
10.Shall maintain an Inspection Book in Form 35
to enable an Inspector to record his
impressions and the defects noticed.
27. 11.Shall maintain reference samples from each
batch.
12.The licensee shall-
i. Forward a statement of the sales effected to
manufacturers, wholesalers, retailers,
hospitals, dispensaries and nursing homes
and Registered Medical Practitioners every
three months.
28. ii. Maintain accounts of all transactions giving
details in a register bound and serially page
numbered and such records shall be
retained for a period of five years or one
year after the expiry of potency, whichever
is later.
29. Accounts of the drugs specified in
Schedule X used for the
manufacture:
• 1.Date of issue.
• 2.Name of the drug.
• 3.Opening balance of stock on the
production day.
• 4.Quantity received, if any, and source from
where received.
• 5.Quantity used in manufacture.
• 6.Balance quantity on hand at the end of the
production day.
• 7.Signature of the person in charge.
30.
31. Accounts of the manufactured drugs:
1.Date of manufacture.
2.Name of the drug.
3.Batch Number.
4.Opening Balance.
5.Quantity manufactured.
6.Quantity sold.
7.Name of the purchaser and his address.
8.Balance quantity at the end of the day.
9.Signature of the person in charge.
32. 13.Shall store drugs specified in Schedule X in
bulk form and when any of such drug is
required for manufacture in a place other
than its place of storage it shall be kept in a
separate place under the direct custody of a
responsible person.
14.Shall comply with the requirements of ‘Good
Manufacturing Practices’ as laid down in
Schedule M.
33. Conditions for grant or renewal of license for
drugs specified in schedule C, C1 (excluding
sch.X and part XB) and those specified in
schedule C, C1 & X:
License for drugs specified in schedule C & C1
other than LVP, sera and vaccines, drugs
specified in part XB and schedule X is issued in
Form no.28.
Licence to manufacture for sale or distribution of
drugs specified under Schedules C and C(1)
(other than LVP, Sera and Vaccines, drugs
specified in Part X-B) and Schedule X shall be
issued in Form 28-B.
34. License to manufacture for sale or for distribution of
LVP, Sera and Vaccines shall be issued in Form 28-
D.
Before the grant of the license in form 28 or 28B or
28D the applicant shall be complied with the
general conditions as specified for grant of license
in Form 25 or 25F and the following condition:-
Shall furnish to the Licensing Authority, if required to
do so, data on the stability of drugs which are likely
to deteriorate for fixing the date of expiry which shall
be printed on the labels of such drugs on the basis of
the data so furnished.
35. Conditions for the grant or renewal of a loan
license to manufacture patent and proprietary
medicines:-
Before license is granted or renewed (in form
25A or 28A) the applicant shall furnish to the
licensing authority evidence and data
justifying that the patent and proprietary
medicine contains the constituent ingredient
in therapeutic prophylactic quantities and
are safe for use in context of the vehicles,
excipients, additives and pharmaceutical
aids used in the formulation.
36. The formulation should be stable under the
recommended conditions of storage and
contain such ingredient in such quantities for
which there is therapeutic justification.
37. Conditions of loan license: (Rule
71B, 74B, 76A, 78A)
Other than conditions for license listed in
form 25 or 28 for Schedule C & C1 drugs the
licensee shall comply with the following:-
1. The licensee shall comply with the
provisions of the Act and further
requirements if any.
38. 2. Licensee shall test each batch of the raw
materials used and finished product
manufactured and shall maintain records or
register showing the particulars of the tests
carried out as specified in schedule U.
Records & registers to be maintained for 5yrs
and 2yrs after the date of the expiry for the
products bearing expiry date on its label.
39. 3. Shall allow the Inspectors to inspect all
registers, records and maintained under these
rules and shall supply to the Inspector
necessary information as he may require for
the purpose of ascertaining whether the
provisions of the Act have been observed.
40. 4. Shall maintain adequate staff and adequate
lab for carrying out tests of strength, quality
and purity of the product manufactured or
make arrangements with approved institution
to carry out such tests, on his behalf.
41. 5. Shall maintain reference sample from each
batch in a quantity of drugs required to carry
out all tests performed on the batch. The
reference sample has to be maintained for
3months from the date of expiry of the product
bearing expiry date for a period of 3yrs from
the date of manufacture for a product not
bearing expiry date.
42. 6. If required by the licensing authority, licensee
shall furnish data on the stability of drugs
which are likely to deteriorate for fixing the
date of expiry, which would be printed on the
label.
7. The licensee shall maintain the inspection
book in form 35.
43. Conditions for the grant or
renewal of ‘Repacking’ license
The following conditions should be complied:-
1. Repacking operation shall be carried out
under hygienic conditions and under
supervision of a competent person.
2. Factory premises shall comply with the
conditions prescribed in schedule M.
44. 3. The applicant shall have adequate
arrangements for carrying out tests for the
strength, quality & purity of the drugs in his
own premises and such unit shall be separate
from repacking unit.
45. 4. Repacking of drugs be carried out at all times
under the supervision of a competent person
approved by the licensing authority.
5. The licensee shall provide and maintain
adequate arrangements for carrying out tests
of the strength, quality and purity of the drugs
either in his own premises or with the
institution approved for the purpose by the
licensing authority.
46. 6. Shall make adequate arrangements
for the storage of drugs.
7. Shall allow the inspector to enter with
or without notice, in any premises,
where packing of drugs is carried on
and to inspect premises and to take
samples of repacked drugs.
47. 8. Testing of raw materials and final product repacked
should be done in the licensee’s own lab or in an
institution approved for the purpose and shall
maintain records showing details of the tests carried
out as specified in schedule U and is to be
maintained for a period of 5yrs from the date of
repacking.
48. 9. Shall allow the inspector to inspect records
and registers maintained under these rules
and supply other necessary information as
required by him.
10.Shall maintain an Inspection book in form 35
to enable Inspector to record his impressions
and defects noticed.
49. 11.Shall maintain samples from each batch of
the drugs repacked by the licensee in a
quantity twice the quantity required to carry
all the tests on a batch. Reference samples to
be maintained for 3months after the expiry
date of the products bearing expiry date on
the label and 3yrs from the date of repacking
in case of other drugs.
50. MANUFACTURE OF DRUGS FOR
EXAMINATION, TEST OR
ANALYSIS
License to be obtained in form 29.
Application to be made in form 30
accompanied with the prescribed fee.
License valid for a period of 1yr from the date
of issue.
Conditions of a license:-
1. drugs manufactured should be exclusively for
the purpose of examination, test or analysis,
and shall carry on the manufacture and
examination, test or analysis.
51. 2. Shall allow any Inspector to enter, with or
without notice, the premises where the drugs
are manufactured and to satisfy himself that
only examination, test or analysis work is
being conducted.
3. Shall keep a record of the quantity of drugs
manufactured for examination, test or analysis
and of any person or persons to whom the
drugs have been supplied.
52. 4. Shall comply with such further requirements of
which the Licensing Authority has given him
not less than one month’s notice.
5. Shall maintain an Inspection Book to enable
an Inspector to record his impressions and
defects noticed.